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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP for the structural analogue substance triethoxy(phenyl)silane (CAS: 780-69-8).The restrictions were that only 4 animals per dose were used and no analytical purity was reported.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VIII.
Author:
Carpenter CP; Weil CS; Smyth HF Jr
Year:
1974
Bibliographic source:
Toxicology and Applied Pharmacology 28(2): 313-9.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
; 4 animals per dose, analytical purity not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino (no other details)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute
- Age at study initiation: 3-5 months
- Weight at study initiation: No data
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Up to 16 mL/kg
Duration of exposure:
24 hours
Doses:
2, 4, and 16 mL/kg
No. of animals per sex per dose:
2 and 4 mL/kg: Four animals
16 mL/kg: Two animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, gross pathology
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 014 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 920 - <= 5 128
Remarks on result:
other: dose given in ml/kg, converted using a specific density of 0.99 g/ml
Mortality:
No deaths in the 2 mL/kg bw group. In the 4 mL/kg bw group 3/4 animals died and in the both animals in the 16 mL/kg bw group died. In the highest dose group deaths were within one day of dosing. The three animals that died in the 4 mL/kg bw died on Days 2 and 4 following removal of dressings.
Clinical signs:
Two rabbits in the 4 mL/kg bw group were found prostate one day after dosing.
Body weight:
One of the rabbits in the 2 mL/kg bw group lost weight, all other surviving animals gained weight.
Gross pathology:
Congestion throughout the lungs and the abdominal viscera were observed. The liver and kidneys were mottled.
Other findings:
Erythema of the skin.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In an acute dermal toxicity study conducted using a protocol that was similar to OECD 402, but not in compliance with GLP (reliability score 2) the LD50 for the structural analogue substance triethoxy(phenyl)silane (CAS: 780-69-8). was 3.18 mL/kg bw in rabbits (equivalent to 3014 mg/kg bw based on a specific density of 0.99 g/mL).